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ZYDUS LIFESCIENCES USFDA
Zydus to buy Assertio for $166.4 millionZydus is acquiring US-based Assertio Holdings for $166.40 million to bolster its specialty oncology presence in the US. The deal, structure...- Zydus Lifesciences acquires US pharma firm Assertio for $166 millionIn a bold move that positions Zydus at the forefront of the U.S. specialty oncology market, the Indian drug manufacturer has secured a $166...
- Zydus Biologics’ Ahmedabad injectable facility gets 7 observations in USFDA inspectionZydus Lifesciences has made headlines as its Zydus Biologics injectable plant in Ahmedabad underwent a USFDA inspection between April 27 an...
- Zydus’ Desidustat gets USFDA orphan drug status for sickle cell diseaseZydus Lifesciences announced a significant development today. The US Food and Drugs Administration has granted Orphan Drug Designation to D...
- Zydus Lifesciences shares in focus after USFDA nod for Verapamil Hydrochloride ER TabletsZydus Lifesciences will be in focus on Wednesday after receiving final USFDA approval for its Verapamil Hydrochloride Extended-Release Tabl...
- Zydus gets USFDA's orphan drug designation for beta-thalassemia productZydus Lifesciences announced a significant development for beta-thalassemia patients. The US Food and Drug Administration has granted Orpha...
- DRL, Zydus recall drugs in US over manufacturing issues: USFDADr Reddy's Laboratories and Zydus Lifesciences are recalling products in the US due to manufacturing issues. Dr Reddy's is recalling muscle...
- Zydus Lifesciences shares in focus after 2 regulatory approvals from Health Canada, USFDAZydus Life shares: Zydus Lifesciences received regulatory approvals from Health Canada for generic Liothyronine tablets and from the USFDA ...
- Zydus Lifesciences gets USFDA nod for Deflazacort oral suspensionZydus Lifesciences Ltd received final USFDA approval for its generic Deflazacort oral suspension (22.75 mg/ml) on Monday. This medication t...
- Zydus Lifesciences gets tentative nod from USFDA for generic blood cancer drugZydus Lifesciences received tentative USFDA approval for its generic Ibrutinib tablets, used to treat various blood cancers like CLL/SLL an...
- Zydus Lifesciences shares in focus after USFDA nod for Celecoxib capsulesZydus Lifesciences gets USFDA nod for Celecoxib capsules. The approval includes various strengths of the drug. It will manufacture the drug...
- Zydus Lifesciences gets USFDA nod to market generic antifungal shampooZydus Lifesciences received approval from the USFDA to market Ketoconazole Shampoo, an antifungal medication, in the US. This approval is f...
- Zydus Lifesciences gets USFDA nod for generic medicationZydus Lifesciences has received approval from the USFDA to market Amantadine extended-release capsules (68.5 mg) and tentative approval for...
- USFDA classifies Zydus Lifesciences Jarod unit as 'official action indicated'Zydus Lifesciences Ltd has been classified as "official action indicated" by the US Food and Drug Administration (FDA) for its Jarod inject...
- Zydus Lifesciences gets USFDA approval for generic acne treatment gelZydus Lifesciences Ltd received final approval from the US Food and Drug Administration (USFDA) to market its generic version of Dapsone ge...
- Zydus Lifesciences gets 6 observations from USFDA for API plantThe US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six ...
- Zydus recalls over 55k bottles of generic drug in USUSFDA said the company is recalling the product due to "failed impurities/ degradation specifications". An out-of-specification (OOS) resul...
- Zydus Lifesciences, Lupin recall products in US market owing to manufacturing issuesZydus initiated the Class II voluntary recall on July 15 this year. Similarly, Baltimore-based Lupin Pharmaceuticals, Inc, is recalling 7,8...
- Zydus gets USFDA nod to market generic blood pressure lowering drugNorepinephrine Bitartrate is indicated for restoration of blood pressure in adult patients with acute hypotensive state. The drug will be m...
- USFDA issues 3 observations on Zydus' Jarod manufacturing unit"We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture ac...
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